Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 7:02 PM
Study NCT ID:
NCT06555406
Status:
RECRUITING
Last Update Posted:
2024-11-26
First Post:
2024-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Lifestyles in Bipolar Disorder: Bay Area Study
Sponsor:
University of California, Berkeley
Organization:
Study Overview
Official Title:
Time-restricted Eating as an Adjunctive Intervention for Bipolar Disorder
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to understand how level of adherence with time-restricted eating (TRE) predicts change in diurnal rhythms (as measured using the amplitude of diurnal peripheral clock gene expression), and how those changes predict lower mania and depressive symptoms, and downstream improvements in quality of life. The effects of diurnal amplitude of clock gene expression is expected to remain significant when controlling for change in glucose tolerance and inflammation. Participants will be enrolled who are already receiving medication treatment for bipolar disorder. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow TRE for eight weeks. Symptoms and Quality of Life will be measured at baseline and during and after the food plan.
Detailed Description:
This is a single-arm trial to examine the effects of time-restricted eating on change in diurnal rhythms, manic and depressive symptoms, and quality of life. In time-restricted eating (TRE), participants will be asked to limit their food intake to a period of 10 hours per day. TRE will be an addition to standard medication approaches in bipolar disorder. Participants who are receiving medical treatment for bipolar disorder and who report at least some sleep or circadian problems will complete baseline measures and then will be asked to follow TRE for 8 weeks, and then will complete measures of symptoms, Quality of Life, and possible treatment mechanisms at the mid-point of treatment, the end of treatment, and at 3 months after the intervention. If successful, this work will help understand key mechanisms through which TRE provides benefits for those with BD.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: